BEUDAMED
    FDA Adverse Event Other Summary report: N

    LIFESTYLE LUBRICATED

    MDR report key: 1698726 · Received May 24, 2010

    Report

    Report Number
    1019632-2010-00009
    Event Type
    Other
    Date Received
    May 24, 2010
    Date of Event
    May 16, 2010
    Report Date
    May 24, 2010
    Manufacturer
    KAREX INDUSTRIES SDN. BHD.
    Product Code
    HIS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER WAS CONTACTED BY PHONE ON (B)(6) 2010 AS A F/U. HE INFORMED THAT HIS PRIMARY DR SUGGESTED THAT HIS PARTNER SHOULD GET TESTED FOR (B)(6) WITHIN 3 TO 6 MONTHS. CUSTOMER STATED THAT HE DOES NOT HAVE UNUSED SAMPLES FROM THIS SAME LOT NUMBER TO BE RETURNED FOR TESTING.

    Description of Event or Problem · 1

    CUSTOMER SENT A COMPLAINT ON (B)(6) 2010 INFORMING THAT HE USED LIFESTYLE'S LUBRICATED CONDOMS AND ONE CONDOM BROKE DURING INTERCOURSE. AFTER FOLLOWING UP WITH HIM BY PHONE ON (B)(6) 2010, CUSTOMER STATED THAT HE WAS (B)(6) (DIAGNOSED BEFORE USING LIFESTYLE CONDOM), HOWEVER, HIS PARTNER WAS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFESTYLE LUBRICATED LUBRICATED LATEX CONDOM HIS KAREX INDUSTRIES SDN. BHD. 08010002DT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other